# K823355: Coulter-Counter #S Plus IV & Lyse S +D

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Electronics, Inc.
- Decided: Dec 28, 1982 after 49 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964988: Coulter AC.T Series Analyzer (1997), 6 descendants of its own
- K973634: Coulter AC.T Diff Analyzer (1997), 4 descendants of its own
- K990352: Coulter AC T Diff 2 Analyzer (1999), 3 descendants of its own
- K955715: Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification) (1996), 3 descendants of its own
- K972354: Abbott Cell-Dyn 3200 System (1997), 2 descendants of its own

Source page: https://510kreport.com/device/K823355
Methodology: https://510kreport.com/methodology